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The Law of the Land: Drug Quality and Security Act

Posted By Administration, Wednesday, December 18, 2013

WASHINGTON, DC - On Wednesday, November 27th, H.R. 3204, the Drug Quality and Security Act, was signed into law by President Obama.

Under the new law, the FDA will gain oversight of certain entities that prepare compounded drugs, which will register with the FDA as "outsourcing facilities.” These facilities will be subject to FDA inspection on a risk-based schedule, as well as federal requirements for current good manufacturing practice and other requirements. Drugs that are produced by compounders that do not register as outsourcing facilities must meet additional conditions described in the law, or face FDA regulation as conventional drug manufacturers. This part of the law emerges in response to the recent and devastating nationwide meningitis outbreak.

State boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state licensed pharmacies, including traditional pharmacy compounding.

The second part of the Drug Quality and Security Act will strengthen the prescription drug supply chain of certain drugs to protect the public from counterfeit, stolen, or otherwise harmful drugs. Manufacturers, repackagers, wholesale drug distributers, and dispensers other than most licensed health care practitioners will be required to provide product and transaction information from each sale and notify the FDA and other stakeholders of illegitimate products.

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